A Phase II Trial of ZD1839 (IRESSA®) for Patients With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- The Number of Patients With Complete or Partial Response Rate of Single Agent ZD1839 in a Patient Population With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction, Using the RECIST 1.0 Criteria.
研究概览
简要总结
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with recurrent or metastatic esophageal or gastroesophageal junction cancer.
详细描述
OBJECTIVES:
Primary
- Explore the activity of single agent gefitinib, in terms of response rate, in a patient population with recurrent or metastatic esophageal or gastroesophageal junction cancer.
Secondary
- Assess the toxicity of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ZD1839
干预措施: ZD1839 (Drug)
结局指标
主要结局
The Number of Patients With Complete or Partial Response Rate of Single Agent ZD1839 in a Patient Population With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction, Using the RECIST 1.0 Criteria.
时间窗: at 8 weeks after initiation of treatment
The overall response is the number of patients with the best response recorded in measurable disease (target lesions) from start to disease progression.Complete response is the number of patients with the disappearance of all target lesions. Partial response is the number of patients with larger than or equal to 30% decrease in sum of the longest diameters from baseline. Progressive disease is larger than or equal to 20% increase in sum of the longest diameters over the smallest sum observed or appearance of new lesions. Stable disease is neither PR nor PD criteria met.
次要结局
未报告次要终点
研究者
David Adelstein, MD
Principal Investigator
Case Comprehensive Cancer Center